ELECSYS PROBNP II IMMUNOASSAY
Received Jun 3, 2019 · Event occurred May 20, 2019
Report 1823260-2019-02056 · MDR key 8663771
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
PROBNP G2Catalog number
04842464190
Lot number
ASKU
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN: (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR 1 PATIENT TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER DID NOT BELIEVE THAT THE PROBNP RESULTS WERE MATCHING THE PATIENT'S CLINICAL PICTURE. THE PROBNP RESULTS FROM BOTH RUN 1 AND RUN 2 WERE CONSIDERED "LESS THAN SENSITIVITY." NO NUMERICAL RESULTS WERE PROVIDED. THE "LESS THAN SENSITIVITY" RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS AS THE PATIENT HAD BEEN DIAGNOSED WITH HEART FAILURE AND ATRIAL FIBRILLATION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E411 SERIAL NUMBER WAS EITHER (B)(4).